Inflammatory Bowel Diseases Clinical Trial
Official title:
A Randomized Controlled Non-Inferiority Trial Comparing Neoplasia Detection During Colonoscopy Screening With and Without Non-Targeted Biopsies in Adult Colonic Inflammatory Bowel Disease
We will conduct a multicenter, parallel-group, non-inferiority RCT in persons with IBD undergoing colorectal neoplasia screening with high-definition white light colonoscopy, comparing a strategy of sampling visible lesions alone to a conventional strategy of sampling both visible lesions as well as normal-appearing mucosa using non-targeted biopsies. The primary outcome is the neoplasia detection rate. The required sample size to demonstrate non-inferiority is 1952 persons.
Status | Recruiting |
Enrollment | 1952 |
Est. completion date | February 28, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Each potential participant must satisfy all of the following criteria to be enrolled in the study. - = 18 years old - Historical endoscopic/histologic disease extending beyond the rectum in UC or involving = 1/3 of colorectum in CD> 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in UC, =1/3 colorectum in CD) - cIBD = 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis) - In symptomatic remission at time of colonoscopy - For CD: Harvey-Bradshaw Index < 541 - For UC or IBDU: Partial Mayo Score = 242 - Major purpose of colonoscopy is neoplasia screening/surveillance - Undergoing colonoscopy with high-definition white light endoscopy Exclusion Criteria: - Persons who are unable to provide informed consent - Persons with a history of colorectal cancer - Persons with prior subtotal or total colectomy (>50% of colon removed) - Persons undergoing repeat colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year - Persons undergoing pancolonic chromoendoscopy or pancolonic virtual chromoendoscopy - Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Boston Bowel Preparation Score of 0 or 1 in any segment) - Incomplete colonoscopy (unable to reach cecum or terminal ileum [if no cecum]) - Moderate-to-severe inflammation (Mayo 2-3) involving = 25% of colorectum or mild inflammation (Mayo 1) involving = 50% of colorectum |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Canada | Nova Scotia Health Authority | Halifax | Nova Scotia |
Canada | Hamilton Health Sciences | Hamilton | Ontario |
Canada | London Health Sciences Centre, University Hospital | London | Ontario |
Canada | McGill University Health Centre | Montreal | Quebec |
Canada | Ottawa Hospital Research Institute | Ottawa | Ontario |
Canada | Eastern Regional Health Authority | St. John's | NFLD |
Canada | Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Canada | University of Manitoba, Health Sciences Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of persons with = 1 neoplastic lesion detected | 4 years | ||
Secondary | Mean number of neoplastic lesions per person | 4 years | ||
Secondary | Proportion of persons with = 1 high grade dysplastic lesion or colorectal cancers detected | 4 years | ||
Secondary | Mean # high grade dysplastic lesions or colorectal cancers per person | 4 years | ||
Secondary | Mean # tissue samples per person | 4 years | ||
Secondary | Mean procedure time | 4 years | ||
Secondary | Rate of major adverse events within 2 weeks of procedure (as per pilot study) | 4 years | ||
Secondary | Proportion of persons referred for colectomy based on neoplastic findings | 4 years | ||
Secondary | Mean time to next recommended surveillance examination | 4 years | ||
Secondary | CRC incidence over five years following study colonoscopy (obtained through patient linkage to provincial cancer registries five years following trial completion) | 4 years |
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